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Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders

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ClinicalTrials.gov Identifier: NCT03019042
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Nanchang Hongdu Hospital of Traditional Chinese Medicine
Nanchang Hospital of Integrated Traditional Chinese and Western Medicine
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Xu Zhou, Jiangxi University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE January 7, 2017
First Posted Date  ICMJE January 12, 2017
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE October 11, 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2018)
Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale) [ Time Frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks ]
Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
Change from baseline to 52 weeks in scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale) [ Time Frame: At baseline and 52 weeks ]
Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
Change History Complete list of historical versions of study NCT03019042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Change from baseline in Gastrin-17 (ng/L) [ Time Frame: At baseline and 52 and 104 weeks ]
    To determine whether the interventions improve gastric function
  • Quantitative results of gastroscopy [ Time Frame: At baseline and 104 weeks ]
    To assess pathologic changes
  • Changes from baseline in body weight (kg) [ Time Frame: At baseline and 52 and 104 weeks ]
    To determine whether the interventions improve body weight
  • Changes from baseline in body mass index (kg/m2) [ Time Frame: At baseline and 52 and 104 weeks ]
    To determine whether the interventions improve body mass index
  • Incidence of any adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
    Assessing by abnormal results (indicated by more or less than 2 × normal reference interval) in the routine blood, urine, and stool tests, liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], total bilirubin [TBIL], direct bilirubin [DBIL], indirect bilirubin [IBIL]), kidney function tests (serum creatinine [SCr] and urea nitrogen [BUN]), and electrocardiogram as well as doctor-evaluated and patient-reported adverse events
  • Incidence of severe adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
    AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death
  • Incidence of drug-related adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
    This outcome is assessed by blinded clinicians in each research center
  • Incidence of withdrawn due to adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Change from baseline to 2, 4, 8, 26, 78 and 104 weeks in scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale) [ Time Frame: At baseline and 2, 4, 8, 26, 78 and 104 weeks ]
    Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
  • Change from baseline to 8, 26, 78 and 104 weeks in Gastrin-17 (ng/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions improve gastric function
  • Quantitative helicobacter pylori [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    Measured by carbon-13-urea breath test
  • Changes from baseline to 2, 4, 8, 26, 52, 78 and 104 weeks in body weight (kg) [ Time Frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions improve body weight
  • Changes from baseline to 2, 4, 8, 26, 52, 78 and 104 weeks in body mass index (kg/m2) [ Time Frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions improve body mass index
  • Changes from baseline to 2, 4, 8, 26, 52, 78 and 104 weeks in systolic blood pressure (mmHg) [ Time Frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions improve systolic blood pressure
  • Changes from baseline to 2, 4, 8, 26, 52, 78 and 104 weeks in diastolic blood pressure (mmHg) [ Time Frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions improve diastolic blood pressure
  • Quantitative results of gastroscopy [ Time Frame: At baseline and 104 weeks ]
  • Number of patients with adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
  • Number of patients with severe adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
  • Number of patients with drug-related adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
    This outcome is assessed by blinded clinicians in each research center
  • Number of patients withdrawn due to adverse events [ Time Frame: From the first dose of intervention up to 104 weeks ]
  • Incidence of abnormal electrocardiogram [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage heart
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in alanine transaminase (U/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage liver function
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in aspartate aminotransferase (U/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage liver function
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in total bilirubin (μmol/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage liver function
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in direct bilirubin (μmol/L) [ Time Frame: at baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage liver function
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in indirect bilirubin (μmol/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage liver function
  • Changes from baseline to 8, 26, 52, 78 and 104 weeks in serum creatinine (μmol/L) [ Time Frame: At baseline and 8, 26, 52, 78 and 104 weeks ]
    To determine whether the interventions are likely to damage kidney function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders
Official Title  ICMJE Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
Brief Summary This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal disorder.
Detailed Description

Chronic gastrointestinal disorders are one of major health problems around the globe. The annual number of patients with chronic gastrointestinal disorders was about 60 to 70 million in American. According to the American statistics in 2014, 4.6 million admissions and 230 thousand patients died due to chronic gastrointestinal disorders. The direct or indirect costs caused by chronic gastrointestinal disorders reached at 142 billion dollars. In China, the incidence of chronic gastrointestinal disorders is 7.3‰ among urban residents, which ranks No. 5 among all diseases and leads to 975 dollars of annually medical costs for per patient.

Along with the development of medical science, traditional Chinese medicine (TCM) is playing an increasingly rule in treatment of chronic gastrointestinal disorders, especially for these mild gastrointestinal disorders which are hard to obtain efficacy in western medicine. Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the Fang Song Dynasty (1102 AD), is composed of ginseng, tuckahoe, atractylodes, baked licorice, coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi, platycodon grandiflorum, white hyacinth bean, and dried orange peel. It has effects of replenishing qi and invigorating spleen (spleen is a TCM conception different from western medicine), as well as penetrating wet and antidiarrheal. It is mainly used for treating the syndrome of spleen qi deficiency, including dyspepsia, chest and stomach distress, borborygmus and diarrhea, limb weakness, thin body, sallow complexion, pale tongue with white and greasy coating, and weak and slow pulse, etc. In the theory of TCM, spleen is the source for producing qi and blood and thus is the root of life. Shen Ling Bai Zhu San could invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and intestine.

To date, Shen Ling Bai Zhu San is mainly used to treat mild gastrointestinal disorder like irritable bowel syndrome and functional dyspepsia in patients with a TCM syndrome of spleen qi deficiency. Pharmacologic study revealed that Shen Ling Bai Zhu San could adjust function of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms.

Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum (two herbs that could not be used as food) from Shen Ling Bai Zhu San, and adds perilla leaf for adapting a dietary therapy. Hou Gu Mi Xi used the main formula of Shen Ling Bai Zhu San, so that it could theoretically maintain the treatment effects. Although the reliable health effects of Shen Ling Bai Zhu San has been proved in previous studies, Hou Gu Mi Xi is optimized in formula and its preparations changed from electuary to rice paste, so that its functional mechanism and efficacy may also be different. Therefore, the investigators plan to perform a hospital-based randomized controlled trial, enroll patients from five hospitals in Nanchang City of Jiangxi Province in China, for assessing efficacy and safety of Hou Gu Mi Xi on Gastrointestinal symptoms and indicators in Patients with Spleen Qi Deficiency and Mild Gastrointestinal Disorder.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Disease
Intervention  ICMJE
  • Dietary Supplement: Hou Gu Mi Xi
    Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
  • Other: placebo
    The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
Study Arms  ICMJE
  • Experimental: Hou Gu Mi Xi
    Patients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats.
    Intervention: Dietary Supplement: Hou Gu Mi Xi
  • Placebo Comparator: placebo
    Patients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats.
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 4, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
406
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient should have mild gastrointestinal disorder without any organic pathologic changes (see exclusion criteria) by diagnosis of gastroscopy within 6 months, which mainly include chronic non-atrophic gastritis, functional gastrointestinal disorders, irritable bowel syndrome, and functional dyspepsia
  • Patient should be status of spleen qi deficiency, that is, meet 2 main symptoms of spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of spleen deficiency, 1 main symptoms of qi deficiency and 1 tongue symptom, or have 1 main symptom of spleen deficiency + 1 main symptom of qi deficiency + 2 secondary symptom + 1 tongue symptom as follow:

    1. Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon
    2. Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity
    3. Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, or polysialia; b) abdominal pain, as a result either patients like warm or press, or remit after meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema
    4. Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur
  • Fourteen years old or more
  • Sign the informed consent

Exclusion Criteria:

  • Patients who have organic pathologic changes, including peptic ulcer, gastrointestinal erosions, gastroesophageal reflux disease, acute gastrointestinal hemorrhage or perforation, structural changes in gastrointestinal structure, gastrointestinal vascular diseases, ileus, and benign tumor
  • Pregnancy or breast-feeding women
  • Allergic to sample or sample composition
  • impaired liver function, including one of following condition: a) total bilirubin > 2 upper limit of normal (ULN); b) alanine transaminase >2 ULN; or c) aspartate aminotransferase >2 ULN
  • impaired kidney function, that is, serum creatinine >2 ULN
  • obviously abnormal electrocardiogram
  • patients who undertaken drugs that could cause damage in stomach and intestine, or patients experience side effects of dyspepsia as undertaking non-steroidal anti-inflammatory drugs, theophylline, oral antibiotic or potassium supplements within 3 months
  • patients who are receiving any agents or other intervention for treating his/her gastrointestinal disorder
  • patients with any malignant tumor
  • patients who have severe mental disorders so that could not control his/her action and coordinate the treatment in this trial.
  • patients who are unwilling to provider personal information and enter this trial
  • patients who cannot understand and sign informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03019042
Other Study ID Numbers  ICMJE JXUTCM-EBM-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The individual participant data are not planned to share.
Responsible Party Xu Zhou, Jiangxi University of Traditional Chinese Medicine
Study Sponsor  ICMJE Jiangxi University of Traditional Chinese Medicine
Collaborators  ICMJE
  • Nanchang Hongdu Hospital of Traditional Chinese Medicine
  • Nanchang Hospital of Integrated Traditional Chinese and Western Medicine
  • The First Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Nanchang University
  • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Investigators  ICMJE
Study Chair: Weifeng Zhu, Ph.D. Jiangxi University of Traditional Chinese Medicine
PRS Account Jiangxi University of Traditional Chinese Medicine
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP